Catalog Number

200501

Brand Name

Hybrid Lubricant

Version/Model Number

5 mL

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K212000,K212000

Product Code

NUC

Product Code Name

Lubricant, Personal

Public Device Record Key

f5c4401b-0f55-4675-a376-e3f96723e0b9

Public Version Date

May 26, 2022

Public Version Number

1

DI Record Publish Date

May 18, 2022

Package DI Number

30850014621781

Quantity per Package

900

Contains DI Package

00850014621780

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Case